Assessment of New Blood Culture Methods on the Microbiological Documentation of Febrile Neutropenia

Completed

• Conditions: Post-chemotherapy; Febrile; Neutropenia
• Interventions: Other: sample blood

• Registration Number: NCT00913042
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Febrile neutropenia are microbiologically documented in only 30% of the cases, and almost exclusively by blood cultures. The reasons for this low documentation are likely multiple: (1) some of these fevers are of non-infectious origin. (2) The bacterial inoculum present in the blood may be low and consequently undetectable by conventional blood cultures.

The primary objective of the study is to assess new blood culture procedures and technics, in order to improve the diagnostic yield of blood cultures during febrile neutropenic episodes.

Detailed Description

Evaluation criteria are 1) proportion of microbiologically documented infections 2) time elapsed from bed side sampling to microbiological diagnostic, in case of positive sample.

The assessed procedures included a large volume of blood, an early incubation made possible by the availability of a culture device in the hematology department, an early warning in case of positive blood culture, bacterial DNA detection in blood, and an early identification of the positive strains and their resistance profile.

We hypothesize that the combination of these different procedures will improve the proportion of microbiologically blood culture from 30 to 45%. One hundred and 20 episodes of febrile neutropenia are necessary to achieve this goal.

Study Timeline

• Study Start: 2008-02
• Status Verified: 2009-04
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• age > 18 y
• first episode of febrile neutropenia during a given neutropenic phase
• PMN < 500/mm3, chemotherapy-induced
• fever > 38°C twice, or < 38°3C once
• signed informed consent

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Exclusion Criteria

• patient already receiving empirical or therapeutic antibacterial after their first episode of febrile neutropenia

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	sample blood	febrile neutropenia patient

Primary Outcome Measures

Name	Time	Method
proportion of microbiologically documented infections	Day 14 from inclusion

Secondary Outcome Measures

Name	Time	Method
clinical status at the end of hospitalisation	Day 30 from inclusion

Trial Locations

Locations (1)

Hematology Department, Paris 12 University Hospital Henri Mondor; 🇫🇷 Creteil, France